Disclose info or face penal action, regulator tells pharma cos again

NEW DELHI: The National Pharmaceutical Pricing Authority (NPPA) has once again warned pharma companies of penal action for failing to submit information on formulations manufactured and marketed by them.

The drug price watchdog will incorporate the information in its online integrated pharmaceutical database management system (IPDMS), which is designed, among other things, to monitor price movements and availability of drugs across India.

Through IPDMS, data on production, import and pricing of scheduled and non-scheduled formulations can be assessed, analysed and used to generate reports.

Earlier in May 2015, the NPPA, in a similar move, had threatened action against companies who were yet to register with the IPDMS.

Taking into account the demand of stakeholders, the regulator once again extended the last date for registration of manufacturers under the IPDMS till February 15, 2016. Earlier, the NPPA had to extended the deadline to January 15, 2016 from December 15, 2016 in spite of the fact that it had warned of penal action in case of noncompliance.

“Failure to submit mandatory data or mandatory returns prescribed under the Drugs (Prices Control) Order, 2013 through the IPDMS will attract penal action under the provisions of the

THE REGULATOR HAD TO EXTEND THE DEADLINE FOR SUBMISSION TWICE IN SPITE OF REPEATED WARNINGS OF PENAL ACTION IN CASE OF NON-COMPLIANCE

DPCO, 2013 read with Essential Commodities (EC) Act 1955,” according to a notice issued by the NPPA last week.

“The NPPA may be constrained to initiate prosecution proceedings against companies, which fail to submit requisite and mandatory forms through the IPDMS,” the regulator warned.

Phar ma companies were directed to file the ‘Form V’ online, stating the name of all formulations manufactured or marketed by them, irrespective of whether they have submitted a hard copy or not. While companies have started filling forms online, they have sought more time since there is large volume of data to be entered.

While the aim of the latest online system is to regulate and scrutinise the drug industry closely, authorities have received poor response from manufacturers.

The government has made the online submission of data mandatory under DPCO, 2013 .